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04/11/19 10:39 AM

#39720 RE: ClosetInvestor #39718

Here it is for the 10Q. The large CMO cost they have been paying over the last year to complete the BLA stops in Q2.

Research and development (“R&D”) expenses, which totaled approximately $9.0 million for the three months ended February 28, 2019, decreased approximately $3.1 million, or 25.3%, over the comparable 2018 quarter principally due to near completion of manufacturing-related expenses in connection with the preparation of our BLA filing. For the quarter ended February 28, 2019, R&D expenditures continue to be primarily devoted to: (1) increased CMC (chemistry, manufacturing and controls) activities to address regulatory compliance requirements for our BLA filing and leronlimab, (2) our pivotal Phase 2b/3 combination therapy trial and our investigative Phase 2b/3 monotherapy trial, and (3) continuing activities necessary to complete the BLA filing with the FDA.

We expect R&D expenses in future periods to level off modestly to reflect completion of manufacturing activities in connection with the CMC portion of our BLA filing in mid-2019